Uveal MelanomaPhase 1/2NCT03052127
Study in Subjects With Small Primary Choroidal Melanoma
A Phase 1/2 study testing Light-activated AU-011 and Laser Activation in people with Uveal Melanoma and Ocular Melanoma, run by Aura Biosciences at 13 sites in United States.
Trial summary
The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma
- What is being tested?
- Light-activated AU-011 and Laser Activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 13 sitesUnited States
- Study dates
- 27 Feb 2017to 26 Jan 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of choroidal melanoma
Who cannot join
- Have known contraindications or sensitivities to the study drug
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, 48105
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Colorado Retina Associates
Denver, Colorado, 80210
Retina Consultants of Carolina, PA
Greenville, South Carolina, 29605
Retina Consultants of Houston
Houston, Texas, 77030
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095
Retina Center
Minneapolis, Minnesota, 55404
Columbia University Medical Center
New York, New York, 10027
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Associated Retinal Consultants, PC
Royal Oak, Michigan, 48073
Retina Consultants of Sacramento
Sacramento, California, 95819
Retina Associates SW, P.C.
Tucson, Arizona, 85710
About this study
Official title: A Phase 1B/2 Open-Label, Ascending Single and Repeat Dose Clinical Trial Designed to Evaluate the Safety and Efficacy of Light-activated AU-011 for the Treatment of Subjects With Small Primary Choroidal Melanoma
The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.
Read the detailed description
This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011 for the treatment of subjects with small primary choroidal melanoma.
Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.
- Conditions
- Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma
- Being tested
- Light-activated AU-011, Laser Activation
- Keywords
- Uveal melanoma, Eye cancer, Ocular melanoma, Choroidal melanoma
- Medical subject headings
- Uveal Melanoma, Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light-activated AU-011Drug
Study treatment
Laser ActivationDevice
Also called PDT Laser
Study treatment
| Study group | Role | What they receive |
|---|---|---|
| Single Low Dose Light-activated AU-011 | Experimental | Low dose Light-activated AU-011 followed by a single laser light application Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| Single Medium Dose Light-activated AU-011 | Experimental | Medium dose Light-activated AU-011 followed by a single laser light application Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| Single High Dose Light-activated AU-011 | Experimental | High dose Light-activated AU-011 followed by a single laser light application Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| 2 Repeat Medium Dose Light-activated AU-011 | Experimental | 2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| 3 Repeat Medium Dose Light-activated AU-011 | Experimental | 3 repeat medium doses of Light-activated AU-011 followed by a single laser light application Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| Single High Dose Light-activated AU-011 x 2 lasers | Experimental | High dose Light-activated AU-011 followed by two laser light applications Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| 3 Repeat High Dose Light-activated AU-011 | Experimental | 3 repeat high doses of Light-activated AU-011 each followed by a single laser light application Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| 3 Repeat High Dose Light-activated AU-011 x 2 lasers | Experimental | 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers | Experimental | Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects) Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| Observation until Documented Growth of Tumor | Experimental | Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| 2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers | Experimental | 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications Receives: Drug: Light-activated AU-011; Device: Laser Activation |
| Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers | Experimental | 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry Receives: Drug: Light-activated AU-011; Device: Laser Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.
Measured: Informed consent through 1-2 years
Secondary outcomes (4)
Immunogenicity (Anti-AU-011 Antibody Analysis)
Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)
Measured: Screening to various time points through 24 months
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound.
Measured: Change from baseline following treatment and at each subsequent visit through Week 52
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Change from Baseline in tumor Largest Basal Diameter (LBD) assessed at each study visit based on fundus photos (millimeters) in participants treated with AU-011.
Measured: Change from baseline following treatment and at each subsequent visit through Week 52
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit.
Measured: Change from baseline following treatment and at each subsequent visit through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start27 Feb 2017
- Primary completion26 Jan 2021
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aura Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abhijit Narvekar, MBBS, Study director, Aura Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052127
- Sponsor's protocol ID
- AU-011-101
- Status last verified
- Jan 2024
- First submitted
- 6 Feb 2017
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B/2 Open-Label, Ascending Single and Repeat Dose Clinical Trial Designed to Evaluate the Safety and Efficacy of Light-activated AU-011 for the Treatment of Subjects With Small Primary Choroidal Melanoma
- ClinicalTrials.gov ID
- NCT03052127
- Acronym / sponsor ID
- AU-011-101
- Conditions
- Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma
- Keywords
- Uveal melanoma, Eye cancer, Ocular melanoma, Choroidal melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Aura BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 1 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.
Detailed description
This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011 for the treatment of subjects with small primary choroidal melanoma.
Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Single Low Dose Light-activated AU-011 | Experimental | Drug: Light-activated AU-011, Device: Laser ActivationLow dose Light-activated AU-011 followed by a single laser light application |
| Single Medium Dose Light-activated AU-011 | Experimental | Drug: Light-activated AU-011, Device: Laser ActivationMedium dose Light-activated AU-011 followed by a single laser light application |
| Single High Dose Light-activated AU-011 | Experimental | Drug: Light-activated AU-011, Device: Laser ActivationHigh dose Light-activated AU-011 followed by a single laser light application |
| 2 Repeat Medium Dose Light-activated AU-011 | Experimental | Drug: Light-activated AU-011, Device: Laser Activation2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application |
| 3 Repeat Medium Dose Light-activated AU-011 | Experimental | Drug: Light-activated AU-011, Device: Laser Activation3 repeat medium doses of Light-activated AU-011 followed by a single laser light application |
| Single High Dose Light-activated AU-011 x 2 lasers | Experimental | Drug: Light-activated AU-011, Device: Laser ActivationHigh dose Light-activated AU-011 followed by two laser light applications |
| 3 Repeat High Dose Light-activated AU-011 | Experimental | Drug: Light-activated AU-011, Device: Laser Activation3 repeat high doses of Light-activated AU-011 each followed by a single laser light application |
| 3 Repeat High Dose Light-activated AU-011 x 2 lasers | Experimental | Drug: Light-activated AU-011, Device: Laser Activation3 repeat high doses of Light-activated AU-011 each followed by two laser light applications |
| Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers | Experimental | Drug: Light-activated AU-011, Device: Laser ActivationExpansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects) |
| Observation until Documented Growth of Tumor | Experimental | Drug: Light-activated AU-011, Device: Laser ActivationObservation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications |
| 2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers | Experimental | Drug: Light-activated AU-011, Device: Laser Activation2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications |
| Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers | Experimental | Drug: Light-activated AU-011, Device: Laser Activation2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of choroidal melanoma
Key exclusion criteria (1 listed)
- Have known contraindications or sensitivities to the study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light-activated AU-011Study treatment | Drug | 2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers, 2 Repeat Medium Dose Light-activated AU-011, 3 Repeat High Dose Light-activated AU-011, 3 Repeat High Dose Light-activated AU-011 x 2 lasers, 3 Repeat Medium Dose Light-activated AU-011, Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers, Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers, Observation until Documented Growth of Tumor, Single High Dose Light-activated AU-011, Single High Dose Light-activated AU-011 x 2 lasers, Single Low Dose Light-activated AU-011, Single Medium Dose Light-activated AU-011 |
| Laser ActivationAlso: PDT LaserStudy treatment | Device | 2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers, 2 Repeat Medium Dose Light-activated AU-011, 3 Repeat High Dose Light-activated AU-011, 3 Repeat High Dose Light-activated AU-011 x 2 lasers, 3 Repeat Medium Dose Light-activated AU-011, Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers, Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers, Observation until Documented Growth of Tumor, Single High Dose Light-activated AU-011, Single High Dose Light-activated AU-011 x 2 lasers, Single Low Dose Light-activated AU-011, Single Medium Dose Light-activated AU-011 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Time frame: Informed consent through 1-2 years
Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.
4 secondary outcomes
Immunogenicity (Anti-AU-011 Antibody Analysis)
Time frame: Screening to various time points through 24 months
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Time frame: Change from baseline following treatment and at each subsequent visit through Week 52
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Time frame: Change from baseline following treatment and at each subsequent visit through Week 52
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Time frame: Change from baseline following treatment and at each subsequent visit through Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhijit Narvekar, MBBS study director
Aura Biosciences
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Light-activated AU-011 and Laser Activation in people with Uveal Melanoma and Ocular Melanoma, run by Aura Biosciences at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 (time frame: Informed consent through 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.